March 20, 2025 • 14 mins
In this episode, we’ll focus on 2 new clinically relevant drug approvals impacting both community and hospital pharmacists – suzetrigine and aztreonam-avibactam. We’ll discuss efficacy data which led to their approval, potential adverse effects and counseling points for pharmacists to be aware of.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:03):
Welcome to the First Fill.
My name is Katie Meyer,and I serve as the Senior Director
of Content Creation at APhAand I'm very excited to be your host.
Today, we're going to discuss
a couple of recent new drug approvalsthat have likely hit your news feed.
The first, aztreonam-avibactamor Emblaveo, the first
and only monobactam/B lactamase inhibitor approvedto treat complicated intra-abdominal infections.
(00:26):
The second, suzetrigine or Journavx,a first-in-class non-opioid
analgesic approved to treat moderateto severe acute pain in adults.
We wanted to be sureto keep you apprised of information
about these two new agentsthat you'll likely begin to see in practice soon.
In part two,I've invited my mentor and dear friend, Remington
Medal Award winner and the go to Rresourcefor all things new drugs, Dr.
(00:50):
Dan Husar to provide us with information about hisapproach to evaluating new drug approvals.
Before we dive in, I'd like to introduce my gueststoday, Yara and Michelle.
Yara and Michelle,why don't you introduce yourself?
Hello, everyone.
My name is Yara Al’ Shaerand I'm the current executive fellow here at APhA.
I'm really excited to be here.
Hello, my name is Michelle Danoand I'm the Associate Director of Content
(01:13):
Creation at APhA. It's great to be here today.
Welcome, Yara and Michelle, I'mso excited to have you both here today.
So let's dive in with our first agent.
We'll start with aztreonam and avibactam.
Michelle, can you tell listeners a little bit about Emblaveo’s path to approval, including relevant
clinical studies?
(01:34):
I sure can.
Emblaveo receivedFDA’s Qualified Infectious Disease
Product (or QIDP)and Fast Track Designation in 2019.
While you’ve likely heard of the Fast TrackDesignation which accelerates drug development
for serious conditions with limited treatmentoptions, QIDP may be less familiar to you..
(01:54):
The QIDP designation providesincentives for development of new antibiotics,
including priority review through fast-trackdesignation and an additional five years
of exclusivity in addition to the typical 5 yearsthat all new chemical entities receive.
As a reminder, this means the FDA cannot approve
generic versions of this drug during this ten yearexclusivity period.
(02:16):
Emblaveo is FDA approved for patients 18 years
and older needingtreatment
of complicated intra-abdominal infectionswho have limited or no alternative options.
Susceptible gram-negative microorganismsinclude escherichia coli, kelbsiella pneumoniae,
klebsiella oxytoca, enterobacter cloacae complex,
(02:38):
citrobacter fruendii complex and serratiamarcescens.
Emblaveo MUST be given in combinationwith metronidazole
as this is how it was studiedin the initial clinical study.
Speaking of that initial clinical study,the study that led to Emblaveo’s approval
iwas recently published in the Lancetof Infectious Diseases and is called Revisit.
(02:59):
Revisit was a prospective, multinational,phase 3, open-label randomized trial
where hospitalized patientswith a complicated intra-abdominal infection
were randomly allocatedto either aztreonam-avibactam
with metronidazole or meropenemwith or without colistin for 5-14 days.
Medication use in patients with pneumonia,either HAP or VAP
(03:21):
was also studiedbut Emblaveo is not approved for that indication.
The primary endpoint was clinical curewithin 3 days before or after day 28.
A total of 422 patients were enrolledand randomly allocated
with 271 having at least one gram negativepathogen identified at baseline.
Most commonly, enterobacterales in 252 patients.
(03:45):
For patients with complicated intra-abdominalinfections, the adjudicated clinical cure rate
was 76.4% for the aztreonam-avibactam
group and 74% for the meropenem group.
Aztreonam-avibactam was generally well tolerated.
Adverse reactionsassociated with use of the medication
were minorand consistent with aztreonam monotherapy.
(04:07):
Thanks, Michelle.
On the topic of adverse effects,can you tell listeners a little bit about what
to be on the lookout for and discussdosing recommendations for the new agent
as well?
As I mentioned above,most adverse reactions in Emblaveo’s
clinical study aligned with those expectedfrom aztreonam monotherapy,
as reflected in the labeling warningsand precautions.
(04:30):
Risk of hypersensitivity reactions, includingrash, flushing and bronchospasm, are noted.
Additionally, toxic epidermal necrosis,also known as TENS,
has occurred with aztreonam in at risk patientsand is therefore listed.
Elevated hepatic transaminases and clostridioides
difficile associateddiarrhea are notable concerns.
(04:54):
If either occurs, discontinuation of the agentand appropriate
monitoring or treatment may be necessary.
The label advises only prescribing Emblaveofor infections that are proven or strongly
suspected to be caused by susceptible bacteriato minimize drug-resistance.
Minor adverse reactions that occurred in over5% of Emblaveo-treated patients
(05:16):
included anemia,diarrhea, hypokalemia and pyrexia.
Emblaveo should be administeredby intravenous infusion over 3 hours.
For adults with an estimated creatinineclearance greater than 50ml/min
the recommended dosage is 2.67gramsaztreonam/0.67 grams
avibactam loading dose
(05:39):
followed by 2 grams aztreonam/0.5grams avibactam
every 6 hours for 5 to 14 days.
Dose adjustments are requiredif creatinine clearance is below
50ml/minas outlined in the prescribing information.
For patients on hemodialysis,an adjusted dose is recommended
and administeredafter hemodialysis on dialysis days.
(06:04):
Thankyou, Michelle for reviewing this new medication.
Overall, it sounds like it will be a useful optionfor patients
with gram negative,multi-drug resistant intra-abdominal infections.
It will be interesting to see if the medicationsindications expand with time.
All right.
Let’s shift gears and switchto our second medication, suzetrigine or Journavx.
Yara, can you tell listenersa little bit about Journavx’s
(06:28):
path to approval,including relevant clinical studies?
Sure!
I’m excited to talk about Journavxalso know as Suzetrigine, a novel class of pain
management medication for treating moderateto severe acute pain in adults.
Journavx is a sodium channel blockerthat reduces pain by targeting pain-signaling
pathways in the peripheral nervous systembefore the signals reach the brain.
(06:52):
Journavx was grantedFDA approval on January 30th, 2025,
along with a Breakthrough Therapy,Fast Track, and Priority Review designations.
This approval is a huge milestone in advancingnon-opioid pain
treatment options, something we as pharmacistshave been anticipating for a while.
Given the urgent need for effectivenon-opioid alternatives.
(07:16):
Its efficacy and safety were evaluatedthrough two phase
two randomized double blind placebocontrolled clinical trials
involving patients with acute painafter ab-dominoplasty or bunionectomy.
In the ab-dominoplasty trial,participants received either high dose Journavx
which consists of a 100 milligramsloading dose followed by a 50 milligram
(07:39):
maintenance dose every 12 hours or mid
dose Journavx consisting of 60 milligramsloading dose
followed by 30 milligramsmaintenance dose every 12 hours
or 5mg of hydrocodone bitartrate and 325
milligrams of acetaminophenevery 6 hours or placebo every 6 hours.
(08:02):
A total of 303 participants were involved
with an 81.5% completion rate.
In the bunionectomy trial,
participants received similarto what was received in the ab-dominoplasty trial
but with the addition of low dose Journavaxand this consists of 20 milligrams
loading dose followed by a ten milligrammaintenance dose every 12 hours.
(08:23):
In this trial,a total of 274 participants were involved
with a 90.1% completion rate.
Some key points include high dose Journavx
showed a mean pain reduction difference of 37.8
compared to placeboin the abdominoplasty trial and 36.8
in the bunionectomy trial over 48 hours.
(08:44):
For the time-weighted sum of the pain-intensitydifference over the 24-hours
the difference was 19.6 in abdominoplasty
and 13.7 in bunionectomy compared to placebo.
Lower doses of Journavx,
hydrocodone-acetaminophen,and placebo showed similar pain relief.
Thanks, Yara.
(09:05):
What are some key counseling pointsthat pharmacists should provide
to patients about this new medication?
Of course.
Journavx comes in 50 mg tablets and is indicated
for the treatment of moderateto severe acute pain in adults.
The recommended starting dose is 100 milligramsby mouth on an empty stomach
(09:25):
at least one hour before or 2 hoursafter food to avoid delays in the onset of action.
Twelve hours after the initial dose,
take 50 milligrams by mouth every 12 hours.
These doses can be taken with or without food.
The most frequently reported sideeffects are pruritus, muscle spasms, increased
(09:46):
creatine, phosphate kinase, also known
CPK, and rash.
It is crucial to educate patientsto stay hydrated by drinking plenty of water
and to immediately report any symptoms of musclepain, weakness or dark urine.
Also, avoid use in patientswith severe hepatic impairment.
Journavx is both a CYP3A4 inducer and substrate,
(10:12):
meaning that concomitant use with strong CYP3A
inhibitors is contraindicatedand should be use with caution
in drugs with Narrow therapeuticindex like Tacrolimus and cyclosporine.
Common Strong CYP3A4 Inhibitors
to avoid include grapefruit juice; antifungalslike ketoconazole, itraconazole,
(10:32):
voriconazole, and posaconazole;macrolide antibiotics like clarithromycin
and erythromycin; protease inhibitorssuch as ritonavir, lopinavir,
and atazanavir and calcium channel blockerslike verapamil and diltiazem.
For patients using hormonal contraceptivescontaining progestins
(10:53):
other than levonorgestreland norethindrone should use additional
nonhormonal contraceptives (such as condoms)or switch to alternative contraceptives.
Options include combined oral contraceptives
containing ethinyl estradioland either levonorgestrel or norethindrone, or
an intrauterine system (IUS).
(11:15):
Please not that these measuresshould be continued during treatment
with Journavxand for 28 days after discontinuation.
There are no established safety and efficacy datafor the use of Journavx during pregnancy to
evaluate the risk of birth defects, miscarriage,
or other adverse maternal or fetal outcomes.
(11:36):
Additionally, there is no safety and efficacy datafor pediatric use.
Thank you so much for that valuable information.
This new medicationsounds like it can certainly be a big one
in terms of the pain landscape
and kind of changethe way we're looking at treatment of pain.
(11:56):
So it'll be interesting to see kindof how clinical recommendations pan out.
All right.
To summarize major takeaways from our time heretoday, Aztreonam-avibactam
was the first monobactam/B lactamase
inhibitor approved in patients 18 years and olderfor the management of complicated
intra-abdominal infectionswho have limited or no alternative options.
(12:21):
The medication should be used judiciouslyto avoid antimicrobial resistance,
and when it is used, a doseadjustment is required for patients
with an estimated CrCl < 50 mL/min.
Adverse reactions found in the clinical studythat was the foundation for its approval
were similar to those of aztreonamand included anemia, diarrhea,
(12:42):
hypokalemia and pyrexia and moreseverely elevation in hepatic transaminases, c.
diff diarrhea, TENS and hypersensitivity.
Suzetrigine is a first in class non-opioid
analgesic approved to treat moderateto severe acute pain in adults.
As a sodium channel blocker, suzetrigine worksby targeting pain-signaling
(13:04):
pathways in the peripheral nervous systembefore the signals reach the brain.
The drug is available in 50 milligrams tablets.
Common side effects include itching,muscle spasms, increased CPK and rash.
It's important for patientsto stay hydrated and report any symptoms
like muscle pain, weakness or dark urine properly.
(13:24):
Because suzetrigine is both a CYP3Ainducer and substrate,
it cannot be used with strong CYP3A inhibitorsor inducers.
Additionally, women using hormonal contraceptives
should use nonhormonal backupmethods or switch to alternatives like combined
oral contraceptivesor an intrauterine system (IUS) during treatment
(13:45):
and for 28 days after stopping the medication.
It is also not recommended for use during pregnancy or in children due to lack of safety data.
All right.
That's all the time we have here for today.
If you enjoyed this month's update on new drugs,be sure to check out our March pharmacy today
CPE article.
Next week,I have the honor of recording episode two
(14:07):
with my mentor and legend in new drugs, Dr.
Dan Hussar.
We’ll be recording live from APhA2025 and Dr.
Hussar will discuss best practices for pharmaciststo consider when evaluating
a new drug based on his years of experiencedoing so himself.
Last but not least, don'tforget to head over to the Learning Library
(14:27):
at learn.pharmacist.comto earn your CPE for this month.
We'd love to hear your feedback. Take care.
Welcome to the First Fill.
My name is Katie Meyer,and I serve as the Senior Director
of Content Creation at APhAand I'm very excited to be your host.
Today, we're going to discuss
a couple of recent new drug approvalsthat have likely hit your news feed.
The first, aztreonam-avibactamor Emblaveo, the first
and only monobactam/B lactamase inhibitor approvedto treat complicated intra-abdominal infections.
(00:26):
The second, suzetrigine or Journavx,a first-in-class non-opioid
analgesic approved to treat moderateto severe acute pain in adults.
We wanted to be sureto keep you apprised of information
about these two new agentsthat you'll likely begin to see in practice soon.
In part two,I've invited my mentor and dear friend, Remington
Medal Award winner and the go to Rresourcefor all things new drugs, Dr.
(00:50):
Dan Husar to provide us with information about hisapproach to evaluating new drug approvals.
Before we dive in, I'd like to introduce my gueststoday, Yara and Michelle.
Yara and Michelle,why don't you introduce yourself?
Hello, everyone.
My name is Yara Al’ Shaerand I'm the current executive fellow here at APhA.
I'm really excited to be here.
Hello, my name is Michelle Danoand I'm the Associate Director of Content
(01:13):
Creation at APhA. It's great to be here today.
Welcome, Yara and Michelle, I'mso excited to have you both here today.
So let's dive in with our first agent.
We'll start with aztreonam and avibactam.
Michelle, can you tell listeners a little bit about Emblaveo’s path to approval, including relevant
clinical studies?
(01:34):
I sure can.
Emblaveo receivedFDA’s Qualified Infectious Disease
Product (or QIDP)and Fast Track Designation in 2019.
While you’ve likely heard of the Fast TrackDesignation which accelerates drug development
for serious conditions with limited treatmentoptions, QIDP may be less familiar to you..
(01:54):
The QIDP designation providesincentives for development of new antibiotics,
including priority review through fast-trackdesignation and an additional five years
of exclusivity in addition to the typical 5 yearsthat all new chemical entities receive.
As a reminder, this means the FDA cannot approve
generic versions of this drug during this ten yearexclusivity period.
(02:16):
Emblaveo is FDA approved for patients 18 years
and older needingtreatment
of complicated intra-abdominal infectionswho have limited or no alternative options.
Susceptible gram-negative microorganismsinclude escherichia coli, kelbsiella pneumoniae,
klebsiella oxytoca, enterobacter cloacae complex,
(02:38):
citrobacter fruendii complex and serratiamarcescens.
Emblaveo MUST be given in combinationwith metronidazole
as this is how it was studiedin the initial clinical study.
Speaking of that initial clinical study,the study that led to Emblaveo’s approval
iwas recently published in the Lancetof Infectious Diseases and is called Revisit.
(02:59):
Revisit was a prospective, multinational,phase 3, open-label randomized trial
where hospitalized patientswith a complicated intra-abdominal infection
were randomly allocatedto either aztreonam-avibactam
with metronidazole or meropenemwith or without colistin for 5-14 days.
Medication use in patients with pneumonia,either HAP or VAP
(03:21):
was also studiedbut Emblaveo is not approved for that indication.
The primary endpoint was clinical curewithin 3 days before or after day 28.
A total of 422 patients were enrolledand randomly allocated
with 271 having at least one gram negativepathogen identified at baseline.
Most commonly, enterobacterales in 252 patients.
(03:45):
For patients with complicated intra-abdominalinfections, the adjudicated clinical cure rate
was 76.4% for the aztreonam-avibactam
group and 74% for the meropenem group.
Aztreonam-avibactam was generally well tolerated.
Adverse reactionsassociated with use of the medication
were minorand consistent with aztreonam monotherapy.
(04:07):
Thanks, Michelle.
On the topic of adverse effects,can you tell listeners a little bit about what
to be on the lookout for and discussdosing recommendations for the new agent
as well?
As I mentioned above,most adverse reactions in Emblaveo’s
clinical study aligned with those expectedfrom aztreonam monotherapy,
as reflected in the labeling warningsand precautions.
(04:30):
Risk of hypersensitivity reactions, includingrash, flushing and bronchospasm, are noted.
Additionally, toxic epidermal necrosis,also known as TENS,
has occurred with aztreonam in at risk patientsand is therefore listed.
Elevated hepatic transaminases and clostridioides
difficile associateddiarrhea are notable concerns.
(04:54):
If either occurs, discontinuation of the agentand appropriate
monitoring or treatment may be necessary.
The label advises only prescribing Emblaveofor infections that are proven or strongly
suspected to be caused by susceptible bacteriato minimize drug-resistance.
Minor adverse reactions that occurred in over5% of Emblaveo-treated patients
(05:16):
included anemia,diarrhea, hypokalemia and pyrexia.
Emblaveo should be administeredby intravenous infusion over 3 hours.
For adults with an estimated creatinineclearance greater than 50ml/min
the recommended dosage is 2.67gramsaztreonam/0.67 grams
avibactam loading dose
(05:39):
followed by 2 grams aztreonam/0.5grams avibactam
every 6 hours for 5 to 14 days.
Dose adjustments are requiredif creatinine clearance is below
50ml/minas outlined in the prescribing information.
For patients on hemodialysis,an adjusted dose is recommended
and administeredafter hemodialysis on dialysis days.
(06:04):
Thankyou, Michelle for reviewing this new medication.
Overall, it sounds like it will be a useful optionfor patients
with gram negative,multi-drug resistant intra-abdominal infections.
It will be interesting to see if the medicationsindications expand with time.
All right.
Let’s shift gears and switchto our second medication, suzetrigine or Journavx.
Yara, can you tell listenersa little bit about Journavx’s
(06:28):
path to approval,including relevant clinical studies?
Sure!
I’m excited to talk about Journavxalso know as Suzetrigine, a novel class of pain
management medication for treating moderateto severe acute pain in adults.
Journavx is a sodium channel blockerthat reduces pain by targeting pain-signaling
pathways in the peripheral nervous systembefore the signals reach the brain.
(06:52):
Journavx was grantedFDA approval on January 30th, 2025,
along with a Breakthrough Therapy,Fast Track, and Priority Review designations.
This approval is a huge milestone in advancingnon-opioid pain
treatment options, something we as pharmacistshave been anticipating for a while.
Given the urgent need for effectivenon-opioid alternatives.
(07:16):
Its efficacy and safety were evaluatedthrough two phase
two randomized double blind placebocontrolled clinical trials
involving patients with acute painafter ab-dominoplasty or bunionectomy.
In the ab-dominoplasty trial,participants received either high dose Journavx
which consists of a 100 milligramsloading dose followed by a 50 milligram
(07:39):
maintenance dose every 12 hours or mid
dose Journavx consisting of 60 milligramsloading dose
followed by 30 milligramsmaintenance dose every 12 hours
or 5mg of hydrocodone bitartrate and 325
milligrams of acetaminophenevery 6 hours or placebo every 6 hours.
(08:02):
A total of 303 participants were involved
with an 81.5% completion rate.
In the bunionectomy trial,
participants received similarto what was received in the ab-dominoplasty trial
but with the addition of low dose Journavaxand this consists of 20 milligrams
loading dose followed by a ten milligrammaintenance dose every 12 hours.
(08:23):
In this trial,a total of 274 participants were involved
with a 90.1% completion rate.
Some key points include high dose Journavx
showed a mean pain reduction difference of 37.8
compared to placeboin the abdominoplasty trial and 36.8
in the bunionectomy trial over 48 hours.
(08:44):
For the time-weighted sum of the pain-intensitydifference over the 24-hours
the difference was 19.6 in abdominoplasty
and 13.7 in bunionectomy compared to placebo.
Lower doses of Journavx,
hydrocodone-acetaminophen,and placebo showed similar pain relief.
Thanks, Yara.
(09:05):
What are some key counseling pointsthat pharmacists should provide
to patients about this new medication?
Of course.
Journavx comes in 50 mg tablets and is indicated
for the treatment of moderateto severe acute pain in adults.
The recommended starting dose is 100 milligramsby mouth on an empty stomach
(09:25):
at least one hour before or 2 hoursafter food to avoid delays in the onset of action.
Twelve hours after the initial dose,
take 50 milligrams by mouth every 12 hours.
These doses can be taken with or without food.
The most frequently reported sideeffects are pruritus, muscle spasms, increased
(09:46):
creatine, phosphate kinase, also known
CPK, and rash.
It is crucial to educate patientsto stay hydrated by drinking plenty of water
and to immediately report any symptoms of musclepain, weakness or dark urine.
Also, avoid use in patientswith severe hepatic impairment.
Journavx is both a CYP3A4 inducer and substrate,
(10:12):
meaning that concomitant use with strong CYP3A
inhibitors is contraindicatedand should be use with caution
in drugs with Narrow therapeuticindex like Tacrolimus and cyclosporine.
Common Strong CYP3A4 Inhibitors
to avoid include grapefruit juice; antifungalslike ketoconazole, itraconazole,
(10:32):
voriconazole, and posaconazole;macrolide antibiotics like clarithromycin
and erythromycin; protease inhibitorssuch as ritonavir, lopinavir,
and atazanavir and calcium channel blockerslike verapamil and diltiazem.
For patients using hormonal contraceptivescontaining progestins
(10:53):
other than levonorgestreland norethindrone should use additional
nonhormonal contraceptives (such as condoms)or switch to alternative contraceptives.
Options include combined oral contraceptives
containing ethinyl estradioland either levonorgestrel or norethindrone, or
an intrauterine system (IUS).
(11:15):
Please not that these measuresshould be continued during treatment
with Journavxand for 28 days after discontinuation.
There are no established safety and efficacy datafor the use of Journavx during pregnancy to
evaluate the risk of birth defects, miscarriage,
or other adverse maternal or fetal outcomes.
(11:36):
Additionally, there is no safety and efficacy datafor pediatric use.
Thank you so much for that valuable information.
This new medicationsounds like it can certainly be a big one
in terms of the pain landscape
and kind of changethe way we're looking at treatment of pain.
(11:56):
So it'll be interesting to see kindof how clinical recommendations pan out.
All right.
To summarize major takeaways from our time heretoday, Aztreonam-avibactam
was the first monobactam/B lactamase
inhibitor approved in patients 18 years and olderfor the management of complicated
intra-abdominal infectionswho have limited or no alternative options.
(12:21):
The medication should be used judiciouslyto avoid antimicrobial resistance,
and when it is used, a doseadjustment is required for patients
with an estimated CrCl < 50 mL/min.
Adverse reactions found in the clinical studythat was the foundation for its approval
were similar to those of aztreonamand included anemia, diarrhea,
(12:42):
hypokalemia and pyrexia and moreseverely elevation in hepatic transaminases, c.
diff diarrhea, TENS and hypersensitivity.
Suzetrigine is a first in class non-opioid
analgesic approved to treat moderateto severe acute pain in adults.
As a sodium channel blocker, suzetrigine worksby targeting pain-signaling
(13:04):
pathways in the peripheral nervous systembefore the signals reach the brain.
The drug is available in 50 milligrams tablets.
Common side effects include itching,muscle spasms, increased CPK and rash.
It's important for patientsto stay hydrated and report any symptoms
like muscle pain, weakness or dark urine properly.
(13:24):
Because suzetrigine is both a CYP3Ainducer and substrate,
it cannot be used with strong CYP3A inhibitorsor inducers.
Additionally, women using hormonal contraceptives
should use nonhormonal backupmethods or switch to alternatives like combined
oral contraceptivesor an intrauterine system (IUS) during treatment
(13:45):
and for 28 days after stopping the medication.
It is also not recommended for use during pregnancy or in children due to lack of safety data.
All right.
That's all the time we have here for today.
If you enjoyed this month's update on new drugs,be sure to check out our March pharmacy today
CPE article.
Next week,I have the honor of recording episode two
(14:07):
with my mentor and legend in new drugs, Dr.
Dan Hussar.
We’ll be recording live from APhA2025 and Dr.
Hussar will discuss best practices for pharmaciststo consider when evaluating
a new drug based on his years of experiencedoing so himself.
Last but not least, don'tforget to head over to the Learning Library
(14:27):
at learn.pharmacist.comto earn your CPE for this month.
We'd love to hear your feedback. Take care.
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